Summary of Field Safety Notices March 2026

07/04/2026
Medical devices Summary of field safety notices (FSN)

We have published a monthly summary of Field Safety Notices (FSN) affecting the Irish market for March 2026 below. 

The naming convention for each document is <product name><manufacturer name><type of action taken by manufacturer.

Documents

Spaceplus Perfusor _B. Braun Melsungen_Advice regarding a software update PDF : 504KB | 05/03/2026 YEASTONE BROTH 11ML_Remel Inc_Advice Regarding Device Removal PDF : 350KB | 31/03/2026 Rifton TRAM and E-Pacer_Schuchmann GmbH & Co. KG_Advice regarding a device modification PDF : 637KB | 31/03/2026 Serascan Diana 3_Diagnostic Grifols S.A_Advice regarding the use of the device PDF : 222KB | 11/03/2026 Vue Motion V12_Philips Medical Systems_Advice regarding a software update PDF : 323KB | 06/02/2026 Thoraflex Hybrid_Vascutek Ltd._Advice regarding updates made to instructions for use PDF : 381KB | 27/02/2026 Various cook medical devices_Cook Incorporated_Advise regarding removal of device PDF : 183KB | 05/03/2026 Mangar Archimedes Bath Lift_Mangar International Ltd_Advice regarding updates made to instructions for use PDF : 923KB | 12/01/2026 Sphere-9 Catheter_Medtronic, Inc._Advice regarding changes or updates made to instructions for use PDF : 196KB | 31/03/2026 Sentinel Cardiology Information Management System_Spacelabs Healthcare Ltd_Advice regarding a software update_CustomerNotice PDF : 286KB | 12/02/2026 Sentinel Cardiology Information Management System_Spacelabs Healthcare Ltd_Advice regarding a software update_FSN PDF : 188KB | 12/02/2026 PK, PKS, Everest Cutting Forceps_Gyrus ACMI, Inc. (Olympus Surgical Technologies America)_Advice regarding a device removal PDF : 233KB | 03/03/2026 Microbact 12L Kit 20 Tests_Oxoid Ltd (ThermoFisher Scientific)_Advice regarding a device removal PDF : 306KB | 27/02/2026 MiniMed insulin pumps_Metronic MiniMed _Advise regarding use of device HCP Letter PDF : 244KB | 27/02/2026 MiniMed insulin pumps_Medtronic MiniMed _Advise regarding use of device_Pump User Letter PDF : 206KB | 27/02/2026 Soltive Laser System_Gyrus ACMI, Inc. (Olympus Surgical Technologies America)_Advice regarding a device modification PDF : 158KB | 16/03/2026 CO2 Laser Systems and VersaPulse PowerSuite (VPPS)_Lumenis Ltd._Advice regarding the use of the device PDF : 577KB | 30/03/2026 Medtronic Inc_My PTM App_Advice regarding software update_Follow up PDF : 371KB | 27/02/2026 Kiwi Omni Vacuum Delivery System_ Clinical Innovations LLC_Advice regarding a device removal PDF : 281KB | 13/03/2026 COMVITA Medihoney_Derma Sciences_Advice Regarding Device Removal PDF : 285KB | 25/02/2026 Adhese2 DCVivaPenKits & DC Cannulas for VivaPen_Ivoclar_Advice regarding device removal_(1) PDF : 978KB | 08/09/2025 CPX 4 Tissue Expanders_Johnson & Johnson MedTech_Advice regarding a device removal PDF : 416KB | 03/03/2026 Infant Child Reduced Energy Electrode, Reduced Energy Electrode Starter Kit_Medical Physio Control Inc_Advice regarding a device removal PDF : 396KB | 31/03/2026 HF-cable, bipolar_Olympus Winter & Ibe GmbH_Advice regarding the use of the device PDF : 272KB | 17/03/2026 KWIK-STIK and LYFO DISK controls_Microbiologics Inc_Advice Regarding the Use of the Device PDF : 333KB | 10/02/2026 BVM Resuscitators_Intersurgical_followup FSN_Advise regardig use of device PDF : 312KB | 04/03/2026 MFM-CMS Central Monitoring System, Vital Signs Monitors, iT20 Telemetry Transmitter, iX12 Patient Monitor__Edan Instruments Inc_Advice regarding the use of the device PDF : 119KB | 27/01/2026 HS55, HS66, GE small, GEV small_GETINGE STERILIZATION AB_Advice Regarding Use of Device PDF : 243KB | 31/03/2026 Dimension Creatinine Flex reagent cartridge_Siemens Healthcare Diagnostics Inc_Advice Regarding Device Removal PDF : 245KB | 31/03/2026 Bowel Health Rapid Test Kit and Sperm Concentration Rapid Test Kit_Hangzhou AllTest Biotech Co Ltd_Advice regarding a device removal PDF : 198KB | 17/02/2026 Atellica CH Creatine Kinase_Siemens_Advice regarding a device removal PDF : 238KB | 31/03/2026 Dual Energy THERMOCOOL SMARTTOUCH SF Bi-Direction_Biosense Webster Inc_Advice regarding the use of the device PDF : 136KB | 24/03/2026 ArmStrong Medical Ltd_Ventillator Circuit_Advice regarding device removal_Follow up PDF : 300KB | 03/02/2026 Adhese2 DCVivaPenKits & DC Cannulas for VivaPen_Ivoclar_Advice regarding device removal_(2) PDF : 1007KB | 31/03/2026 Armstrong Medical Ltd_APL Valve Component_Advice regarding the use of device PDF : 225KB | 09/03/2026 Centricity Universal Viewer_GE Healthcare_Advice regarding a software update PDF : 202KB | 31/03/2026 Angiographic Catheters_AngioDynamics, Inc._Advice regarding a device removal PDF : 253KB | 03/03/2026 Allura and Azurion Systems_Philips Medical Systems_Advice regarding a device modification PDF : 408KB | 26/02/2026 ACCOLADE Device Family_Boston Scientific Corporation_Advice regarding a software update_Product Advisory Info PDF : 551KB | 31/03/2026 ACCOLADE Device Family_Boston Scientific Corporation_Advice regarding a software update_FSN1 PDF : 717KB | 30/03/2026 ACCOLADE Device Family_Boston Scientific Corporation_Advice regarding a software update_FSN3 PDF : 146KB | 30/03/2026 Access Total T4 Calibrator_Beckman Coulter, Inc._Advice Regarding Device Removal PDF : 165KB | 20/03/2026 ACCOLADE Device Family_Boston Scientific Corporation_Advice regarding a software update_FSN2 PDF : 147KB | 30/03/2026